A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324 (JADE)

March 17, 2026 updated by: Ollin Biosciences, Inc.

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Two Different Formulations of Intravitreal OLN324 in Adult Participants With Either Neovascular (Wet) Age-related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Two Different Formulations of Intravitreal OLN324 in Adult Participants With Either Neovascular (Wet) Age-related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612-4368
        • Arecibo, Puerto Rico
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix, AZ
    • California
      • Glendale, California, United States, 91204
        • Glendale, CA
      • Pasadena, California, United States, 91107
        • Pasadena, CA
      • Sacramento, California, United States, 95825
        • Sacramento, CA
      • Walnut Creek, California, United States, 94598
        • Walnut Creek, CA
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Waterford, CT
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Fort Myers, FL
      • St. Petersburg, Florida, United States, 33711
        • Saint Petersburg, FL
      • Winter Haven, Florida, United States, 33880
        • Winter Haven, FL
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • Oak Forest, IL
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Hagerstown, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Grand Rapids, MI
    • Nevada
      • Reno, Nevada, United States, 89502
        • Reno, NV
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • Wake Forest, NC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Tulsa, OK
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Springfield, OR
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Germantown, TN
    • Texas
      • Abilene, Texas, United States, 79606
        • Abilene, TX
      • Arlington, Texas, United States, 76012
        • Arlington, TX
      • Austin, Texas, United States, 78705
        • Austin, TX
      • Bellaire, Texas, United States, 77401
        • Bellaire, TX
      • Dallas, Texas, United States, 75231
        • Dallas, TX
      • Katy, Texas, United States, 77494
        • Katy, TX
      • Plano, Texas, United States, 75075
        • Plano, TX
      • Round Rock, Texas, United States, 78681
        • Round Rock, TX
      • San Antonio, Texas, United States, 78240
        • San Antonio, TX
      • San Marcos, Texas, United States, 78666
        • San Marcos, TX
      • Schertz, Texas, United States, 78154
        • Schertz, TX
      • The Woodlands, Texas, United States, 77384
        • The Woodlands, TX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
  • DME patients must be ≥ 18 years of age, nAMD patients must be ≥ 50 years of age
  • Diagnosis of either DME or nAMD. nAMD patients must be treatment naïve. DME patients can be either treatment naïve or treatment experienced
  • DME patients must have best corrected visual acuity of 78 to 25 letters
  • nAMD patients must have best corrected visual acuity of 80 to 25 letters

Exclusion Criteria:

  • If pregnant or breastfeeding
  • History of cataract surgery and/or Yttrium-Aluminum Garnet (YAG) for removal of posterior capsular opacification (PCO) within 90 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: faricimab 6mg
Drug: Faricimab
Intravitreal Injection
Experimental: OLN324 2mg
Drug: OLN324
Intravitreal Injection
Experimental: OLN324 4mg
Drug: OLN324
Intravitreal Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Week 12 and Week 20
Week 12 and Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ollin Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

December 9, 2025

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLN324-CP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Macular Edema (DME)

Clinical Trials on Faricimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe